Trial document





This trial has been registered retrospectively.
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  DRKS00015734

Trial Description

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Title

Intraoperative hydroxyethyl starch infusion reduces the incidence of anastomotic leakage after elective laparoscopic anterior rectal resection

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In this observational study we show that the intraoperative infusion of hydroxyethyl starch reduces the incidence of anastomotic leakage after laparoscopic anterior rectal resection.

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Brief Summary in Scientific Language

Background: The effect of intraoperative infusion of hydroxyethyl starch (HES) on anastomotic leakage (AL) after anterior rectal resection is not known. Experimental and clinical data suggest an optimized splanchnic perfusion and inhibition of metalloproteinases by HES which both may be protective against AL.
Methods: Data were drawn from a local database of all patients who had elective surgery for rectal carcinoma with no additional malignancy between January 01, 2010 and December 31, 2014. The primary goal of that database was to analyze the effects of an epidural analgesia on long-term survival. In the actual secondary analysis we used a stepwise logistic regression investigating the effects of intraoperative HES infusion on the incidence of AL. From a total of 206 patients, 178 had an anterior rectal resection with anastomosis. Two patients, who required intraoperative blood transfusion and two patients with missing data were excluded, 174 patients were analyzed.
Results: Overall AL rate was 11.5%. Of the 174 patients, 79 had an intraoperative infusion of HES, 95 patients had not. Three factors were independently associated with the development of AL: An experienced surgeon (p = 0.002) and intraoperative infusion of HES (p = 0.004) resulted in a decreased incidence of AL, whereas a low anastomosis (< 5 cm ab ano) increased the risk for AL (p = 0.033).
Conclusion: Intraoperative HES infusion may reduce the incidence of anastomotic leakage after elective laparoscopic anterior rectal resection.

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Organizational Data

  •   DRKS00015734
  •   2018/11/07
  •   [---]*
  •   yes
  •   Approved
  •   F-2018-070, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   In this arm of the retrospective analysis, all patients undergoing elective laparascopic anterior rectal resection for cancer surgery during the study period received intraoperative hydroxyethylstarch infusion at the discretion of the attending anesthesiologist.
  •   In this arm of the retrospective analysis, all patients undergoing elective laparascopic anterior rectal resection for cancer surgery during the study period received intraoperative solely crystalloid infusion at the discretion of the attending anesthesiologist.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Does intraoperative infusion of hydroxyethyl starch reduce the incidence of anastomotic leakage after anterior rectal resection? Results of an observational study.

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Secondary Outcome

No secondary outcome.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/21
  •   175
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

All patients undergoing elective laparascopic anterior rectal resection for cancer surgery during the study period.

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Exclusion Criteria

Missing data (2 patients). Intraoperativ transfusion (2 patients). No intraabdominal anastomosis (28 patients).

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Addresses

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    • Klinik für Anästhesiologie und Intensivmedizin,Schwarzwald-Baar Klinikum
    • Mr.  Prof. Dr.  Albert  Benzing 
    • Klinikstr. 11
    • 78048  Villingen-Schwenningen
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin,Schwarzwald-Baar Klinikum
    • Mr.  Prof. Dr.  Albert  Benizng 
    • Klinikstrasse 11
    • 78052  Villingen-Schwenningen
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin,Schwarzwald-Baar Klinikum
    • Mr.  Prof. Dr.  Albert  Benizng 
    • Klinikstrasse 11
    • 78052  Villingen-Schwenningen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Intensivmedizin,Schwarzwald-Baar Klinikum
    • Mr.  Prof. Dr.  Albert  Benzing 
    • Klinikstr. 11
    • 78048  Villingen-Schwenningen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.